510(k) · Cleared
ClearedBactrack Select Breathalyzer, Model S80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Khn Solutions, LLC · DJZ Devices, Breath Trapping, Alcohol
Cleared on Mar 24, 2009 as substantially equivalent to K080848 (Q3 Innovations, LLC, 2008) after a 74-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Mar 24, 2009
- Review
- 74 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041334 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 2 generations backK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
- 1 generation backK080848 Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008
- This deviceK090067 Bactrack Select Breathalyzer, Model S80Khn Solutions, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| −2 | K043188 | Alcohawk Precision | Q3 Innovations, LLC | 2005 | — |
| −1 | K080848 | Alcohawk Model PT500 Digital Alcohol Detector | Q3 Innovations, LLC | 2008 | — |
| 0 (this device) | K090067 | Bactrack Select Breathalyzer, Model S80 | Khn Solutions, LLC | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080848 | Alcohawk Model PT500 Digital Alcohol DetectorSummary page 1…assification Name/Product Code: Devices, breath trapping, alcohol, DJZ Common/Usual Name: Breath Alcohol Tester 2. Equivalent legally marketed device: AlcoHAWK PT500 K080848 Q3 Innovations LLC. 3. Indications for Use (intended use) This device is intended to measure alcohol in human breath. Measure… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K080848.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DJZ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DJZ
240in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJZ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJZ
3in 2025
MAUDE reports naming product code DJZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 2 |
| 2008 | 5 | 149 | 0 | 0 |
| 2009 | 5 | 122 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 240 | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090067: Bactrack Select Breathalyzer, Model S80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026